XOMA Announces Encouraging Interim Results From Gevokizumab

BERKELEY, Calif., Jan. 7, 2013 (GLOBE NEWSWIRE) -- XOMA
Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, today announced preliminary
top-line data from an interim analysis of its Phase 2
proof-of-concept (POC) study to evaluate the safety and efficacy of
gevokizumab, a potent modulator of interleukin-1 beta (IL-1 beta),
for the treatment of the inflammatory facial lesions seen in
patients with moderate to severe acne vulgaris.

The Phase 2 POC study is a double-blind randomized comparison of
gevokizumab 0.2mg/kg and 0.6mg/kg versus placebo given
subcutaneously once per month for three consecutive months.
Investigators have enrolled a total of approximately 125 patients
to date, and the interim results are based on up to 92 patients
with available data. In line with FDA guidance, inflammatory lesion
counts, the primary endpoint in this trial, and overall acne
severity as assessed by responder analysis of the Investigator
Global Assessment (IGA), defined as at least a two-point
improvement on a five-point scale, were measured at different time
points up to Day 84. The study was designed to have 80 percent
power to detect at least an absolute difference of 15 versus
placebo in the mean inflammatory lesion count at Day 84 with
statistical significance defined as p less than or equal to
0.10.

The 0.6mg/kg dose group showed a statistically significant
reduction of
19 in mean inflammatory lesion count on Day 42 compared to a
reduction of 13 in the placebo treated group (p=0.077). Each of the
groups had a mean baseline of approximately 31 inflammatory
lesions. The magnitude of the difference was substantially
maintained throughout the study, but differences at later
measurement points were not statistically significant. The 0.6mg/kg
dose group demonstrated both a clinically and statistically
significant improvement in IGA at Day 84, showing a 31 percent
responder rate versus a 5 percent responder rate in the placebo
group (p= 0.031). The 0.2mg/kg dose group showed no clinically or
statistically significant differences from placebo at any time
point in inflammatory lesion count or in IGA.

Gevokizumab appeared to be well tolerated in the trial, and
incidence of adverse events was comparable between both active
groups and placebo. The study was dosed in a mg/kg fashion with
mean patient weights of approximately 74 kg, thus actively treated
patients received mean absolute doses at the 0.2mg/kg and the
0.6mg/kg of around 15 mg and 45 mg respectively.

"The preliminary results of this initial proof-of-concept trial
are encouraging as we demonstrated clear activity according to the
IGA parameter, and we also established a no-effect dose. The data
from our analysis of inflammatory lesion count demonstrate
statistical significance at the 0.6mg/kg dose for the Day 42
measurement. I believe the safety profile and preliminary activity
results seen with gevokizumab clearly warrant further evaluation in
moderate to severe inflammatory acne, including with higher doses
we are using in our other studies. The study also provided key
information on placebo response rates in this specific acne
population, and this knowledge will be useful in the design of
future trials," offered Paul Rubin, M.D., Senior Vice President of
Research and Development and Chief Medical Officer of XOMA.

"We designed XOMA's Phase 2 proof-of-concept program to expand
our understanding of the potential for gevokizumab to treat several
different diseases characterized by IL-1 beta over-expression. We
are encouraged by these preliminary top-line results, which
demonstrate gevokizumab's potential to treat inflammatory lesions
and affect the physicians overall assessment associated with
moderate to severe acne vulgaris," commented John Varian, Chief
Executive Officer of XOMA. "We await the complete data from this
trial and the results from our Phase
2 POC studies in erosive osteoarthritis of the hand and
non-infectious scleritis, which are expected later this year. At
that time, we and our partner, Servier, expect to be able to
determine our next indication to follow non-infectious uveitis into
Phase 3 development."

The data from inflammatory lesion count at each visit, as well
as Investigator Global Assessment at Day 84, are available on the
home page of the XOMA website, www.xoma.com.

About moderate to severe acne vulgaris

Moderate to severe acne vulgaris is estimated to affect
approximately three to four million people in the U.S. Acne is
characterized by the presence of a bacterium known as
Proprionumbacterium acne, which promotes the production of
proinflammatory substances including IL-1 beta in experimental
models of the disease.

Moderate to severe acne that does not respond to topical agents
is often treated with orally administered antibiotics. For the most
severe, non-responsive acne, isotretinoin (an oral retinoid drug)
treatment may be prescribed, although it is only available through
a restricted distribution program due to its side effect
profile.

About Gevokizumab

Gevokizumab (XOMA 052) is a potent monoclonal antibody with
unique allosteric modulating properties and the potential to treat
patients with a wide variety of inflammatory and other diseases.
Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a
pro-inflammatory cytokine that has been shown to be involved in
non-infectious uveitis, including Behcet's uveitis, cardiovascular
disease, and other auto-inflammatory diseases. By binding to IL-1
beta, gevokizumab inhibits the activation of the IL-1 receptor,
thereby modulating the cellular signaling events that produce
inflammation. Gevokizumab has been studied in over 500 patients,
with approximately 300 patients on treatment for six months, and
has been shown to be well-tolerated.
Information about gevokizumab clinical studies can be found at
www.clinicaltrials.gov.

About XOMA

XOMA combines a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research, with its recently launched commercial operations. XOMA
focuses its antibody research and development on allosteric
modulation, which offers opportunities for new classes of
therapeutic antibodies to treat a wide range of human diseases.
XOMA is developing its lead product gevokizumab (IL-1 beta
modulating antibody) with Servier through a global Phase 3 program
in non-infectious uveitis and ongoing proof-of-concept studies in
other IL-1-mediated diseases. XOMA's scientific research also
produced the XMet program, which consists of three classes of
preclinical antibodies, including Selective Insulin Receptor
Modulators (SIRMs) that could have a major effect on the treatment
of diabetes.

More detailed information can be found at www.xoma.com.

The XOMA Corporation logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=5960

About Servier

Servier is a privately run French research-based pharmaceutical
company. Current therapeutic domains for Servier medicines are
cardiovascular, metabolic, neurological, psychiatric and bone and
joint diseases, as well as oncology. Servier is established in 140
countries worldwide with over 20,000 employees and a 2011 turnover
of EURO3.9 billion. Servier invests 25% of its turnover in
R&D.

More information is available at: www.servier.com

Forward-Looking Statements

Certain statements contained in this press release including,
but not limited to, statements related to XOMA's Phase 2 POC
program, the data generated by studies in that program and the
indications of future Phase 3 studies on gevokizumab, or that
otherwise relate to future periods are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. These
statements are based on assumptions that may not prove accurate,
and actual results could differ materially from those anticipated
due to certain risks inherent in the biotechnology industry and for
companies engaged in the development of new products in a regulated
market. Potential risks to XOMA meeting these expectations are
described in more detail in XOMA's most recent filing on Form 10-K
and in other SEC filings. Consider such risks carefully when
considering XOMA's prospects. Any forward-looking statement in this
press release represents XOMA's views only as of the date of this
press release and should not be relied upon as representing its
views as of any subsequent date. XOMA disclaims any obligation to
update any forward-looking statement, except as required by
applicable law.

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